Natasha Withers
- Role
- Senior Manager, Quality Risk Management at Biogen
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Natasha Withers
I am responsible for developing and implementing a quality framework for processes and…
Experience
Senior Manager, Quality Risk Management
Sep 2021 — Present
Supports the GCP and GLP Quality Risk Management Advisors in providing oversight for GCP and GLP across Biogen R&D, identifying, assessing, advising on and overseeing mitigation of impactful quality risks, providing input into R&D Quality & Strategic Operations (QSO) leadership and functional quality leads. Support the GCP/GLP Audit Program for R&D, including but not limited to GCP/GLP Global Affiliate Audits, GCP/GLP Vendor Audits, and GCP/GLP Internal Process/QMS Audits Supports the conduct of quality risk management activities at the process level across R&D Supports the execution of a regulatory intelligence process for R&D Supports the execution of proactive inspection readiness to create a state of inspection readiness across study teams Manages and oversees sponsor inspection readiness preparations, inspection conduct, response and adherence to inspection CAPA commitments
Skills
- CRO
- Quality Control
- Quality Assurance
- Clinical Data Management
- Clinical Trials
- Training
- Pharmaceutical Industry
- Sop
- Fda
- Clinical Research
- 21 Cfr Part 11
- Gcp
- Ctms
- Clinical Development
- Edc
- Operational Support
- Oncology
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